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Title 21 Part 884 → Subpart B → §884.1425

Title 21 → Chapter I → Subchapter H → Part 884 → Subpart B → §884.1425

Electronic Code of Federal Regulations e-CFR

Title 21 Part 884 → Subpart B → §884.1425

e-CFR data is current as of January 27, 2020

Title 21Chapter ISubchapter HPart 884Subpart B → §884.1425


Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart B—Obstetrical and Gynecological Diagnostic Devices


§884.1425   Perineometer.

(a) Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.

(b) Classification. Class II (performance standards).